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Single Dose Vials

An important message from the President

The Centers for Disease Control and Prevention (CDC) released a Morbidity and Mortality Weekly Report (MMWR) yesterday highlighting the risk of infection with interventional pain procedures. The report emphasized serious complications associated with the reuse of single dose vials (SDVs). Indeed, "unsafe injection practices” have been highlighted in many recent public media and governmental campaigns. The CDC formed its Safe Injection Practices Coalition in 2009 and, in the summer of 2011, launched a media campaign related to safe injection practices entitled ‘One and Only.’ Last September, the General Accounting Office (GAO) was commissioned by Congressman Pallone [(D) – NJ6] to investigate the "frequent outbreaks of blood-borne pathogens in healthcare settings due to unsafe injection practices.” Most recently, in June of this year, a Centers for Medicare and Medicaid Services (CMS) memorandum from the Office of Clinical Standards and Quality/Survey & Certification Group was sent to State Survey Agency Directors regarding the reuse of SDVs. During this time there has been much information, as well as misinformation, disseminated regarding infection control policies for pain management injection procedures. This short article will update our membership on the latest policies regarding "safe practice”, review the relevant evidence, and clarify where the International Spine Intervention Society stands on these issues and what we are doing on your behalf.

For interventional pain management (IPM) specialists and their clinical staff, four primary areas of concern have been highlighted as "unsafe injection practices”:

The reuse of syringes and needles between patients,

Failure to don a face mask during the performance of a spinal injection,

Improper pooling or diluting of medications, and

The reuse of SDVs between patients.

To be clear, breaches in other infection control standards have been identified in infection outbreaks in pain clinics, including improper hand washing technique, improper skin cleansing, and improper medication storage, but the primary concerns cited by state and governmental infection control specialists have focused on the four concerns listed above.

The first area of concern should be self-evident: it is undeniably unsafe to ever reuse a disposable syringe or needle for more than one patient, or to reuse a needle or syringe which has been used for any patient to subsequently access any medication vial. Several serious infectious disease outbreaks have been documented from reusing syringes and needles in this manner.

The appropriate use of face masks during the performance of spinal interventions and the improper pooling or diluting of medications will be addressed in an upcoming edition of International Spine Intervention Society e-News.

The most contentious issue involves the use of SDVs for multiple patients. The crux of this issue reflects a simple reality – single dose vials of many of the most commonly used medications for pain intervention procedures, including contrast media, are not readily available in FDA-approved packaging at a reasonable price. It is safe to say that IPM specialists would not be ensnared in this debate if reasonably priced and sized vials of sterile medication were readily available. Several perversities in the current packaging of commonly used injectables compound this problem: smaller vials paradoxically often cost more than larger vials, and typically represent more than a doubling of per mL cost; 2, 3, or 5 mL vials of intravenous contrast, such as Isovue or Omnipaque, in concentrations typically used for pain interventions are not currently manufactured; and, given the standard of bundled reimbursements, there are significant price considerations, with some clinics paying as much as $50 for a 50 mL vial of Omnipaque 240, and even higher amounts for 10 or 20 mL vials.

A lack of commercially available alternatives, coupled with the recent decreases in reimbursement across the board for interventional pain procedures, have led many practitioners – believing that they are following safe practices and wishing to curb rocketing healthcare costs and drug shortages – to reuse SDVs for multiple patients. As noted in the MMWR, the consequences can be severe. Use of SDVs on multiple patients has been specifically targeted since contamination of a reservoir of medication can turn a case of a single patient infection into an infectious disease outbreak. While breaches in sterile technique resulting in an infection in a single patient may be devastating, an outbreak is disastrous.

ISIS has always strived to improve the quality of patient care by advocating good science. The essence of good science critically revolves around the evaluation of data. To that end, International Spine Intervention Society leadership representatives held a series of conference calls and email exchanges over the past several months with epidemiologists and staff from CDC’s Atlanta and Washington offices. The CDC representatives were gracious with their time and expertise; they took time to listen to our concerns and to try to grasp the financial and access-to-care repercussions of their recommendations. They also devoted hours of teleconference time and enlisted multiple specialists in the various areas of concern. They were transparent with their evidence, sharing with us both published and unpublished public health investigations related to outbreaks in IPM clinics from 2007 to the present.

During these sessions, the International Spine Intervention Society thoroughly reviewed nine documented outbreaks involving pain clinics, including five unpublished reports. One of the five unpublished reports (#5 in the table below) formed the basis of the MMWR report. The outbreaks ranged from two patients infected with Hepatitis C in one clinic to 24 patients with S. aureus infections in another. The evidence was sobering. The use of SDVs for multiple patients has causally contributed to infectious disease outbreaks from interventional pain procedures, resulting in severe morbidity and even mortality. While numerous breaches in appropriate sterile technique were cited in most of the investigations, the case reported in MMWR of a methicillin-resistant Staphylococcus aureus (MRSA) outbreak involving a pain management clinic in Arizona left little doubt that the common denominator was reuse of an SDV. The only other safety breach in this outbreak was failure to don a face mask during the procedures. However, the lack of face mask use could not have accounted for the outbreak. As the CDC report states, "All of the patients with MRSA infections received diluted contrast from the afternoon vial… The three patients with MRSA infections went to a local hospital 4–8 days after their outpatient pain remediation procedures. They required inpatient care for severe infections, including acute mediastinitis, bacterial meningitis, epidural abscess, and sepsis. Hospitalization ranged from 9 to 41 days, with additional long-term care in an acute-care facility required for one patient. The fourth recipient of diluted contrast from the afternoon vial was found deceased at home, 6 days after treatment at the clinic. The cause of death was reported as multiple-drug overdose; however, invasive MRSA infection could not be ruled out.”

Use of single-dose vials for >1 patient; lack of hand hygiene prior to procedures; injection site not properly cleaned

3

3. (2009)

S. aureus

Bloodstream infection, Epidural abscess

8

7 (88)

Reuse of syringe to access medication vials used for >1 patient; Use of single-dose vials of contrast for >1 patient; improper storage of medication vials; masks not worn by staff performing epidural injections

Single-dose vials of contrast were diluted with saline and then used for >1 patient; masks not worn by staff performing spinal injections

6

Notes:

aUnsafe injection practices attributed to a single anesthesiologist who practiced at 2 different outpatient clinics. Number of outbreak-associated infections reflects infections identified at the pain management clinic.

The International Spine Intervention Society has worked tirelessly to advocate for best practices in the field of pain interventions, and to find reasonable, safe, and affordable solutions for our membership and their patients. We have delved into regulations and practices surrounding pharmacy compounding and repackaging, USP 797 Standards, FDA rules regarding repackaging of medications and relating to manufacturers changing vial sizes, and CMS practice expense calculations that make up the relative value units (RVUs) for IPM procedures. We elicited the help of the CDC in clarifying existing pharmacological repackaging regulations. This led to collaboration between CMS and CDC that resulted in the June CMS memorandum from the Office of Clinical Standards and Quality/Survey & Certification Group. The CDC has also worked with the FDA to address other questions posed by ISIS involving manufacturers of contrast media.

The International Spine Intervention Society has worked with the American Society for Anesthesiologists (ASA) in reviewing policies for safe injection practices. The ASA has long been an outspoken advocate for patient safety, and convened a task force on infectious complications associated with neuraxial interventions in 2010 that resulted in a published practice advisory for the prevention, diagnosis, and management of infectious complications associated with these techniques. ISIS invited the ASA to join a CDC teleconference and to review the CDC’s investigations and data on outbreaks in IPM practices. We have also been in communication with the North American Spine Society, American Society for Interventional Pain Physicians, and American Academy of Pain Medicine, and will be reaching out to our colleagues at the American Academy of Physical Medicine and Rehabilitation, American Academy of Orthopaedic Surgeons, and the radiology societies. Ensuring the safety of our patients is critical, and inter-society collaboration is paramount to fostering the delivery of the highest quality, safest care to patients.

As a result of these discussions, the International Spine Intervention Society has concluded that a multi-prong strategy is imperative, and that working with our governmental agencies is more likely to result in support for positive and meaningful change. As a start, we are working to provide our members alternatives in accessing safe and cost-effective small volume SDV packaging for contrast media. This will begin with the development of a list of questions that a provider might want to ask of a compounding or repackaging pharmacy to assure that they are using Current Good Manufacturing Practices (CGMPs), as outlined by the FDA. We are soliciting information from compounding and repackaging pharmacies to better inform our members of available alternatives to existing major manufacturers of large volume SDVs. Concurrently, we will continue to work on urging major manufacturers of injectable contrast to produce appropriately sized and reasonably priced SDVs for pain interventions. This will include enlisting assistance from concerned government agencies as well as from multiple stakeholder societies. We are also considering working within the AMA-CPT Relative Value Scale Update Committee (RUC) to amend the practice expense apportionment for pain injections to reflect escalating medication costs.

We will continue to update our membership on the best practices related to infection control and interventional pain procedures. Please review links at the end of this article for important relevant literature and web resources. Also, be sure to read upcoming articles in future International Spine Intervention Society e-News editions on safe injection practices. As always, the International Spine Intervention Society remains committed to being your trusted source for information about spine interventions.

To protect our patients and ourselves, we strongly encourage all of our members to review their current infection control practices. The CDC provides a free CME activity addressing unsafe injection practices, an injection safety checklist,FAQs and numerous other resources to help you ensure that you and your colleagues are following critical patient safety standards. In addition, the CDC has published an injection safety toolkit that includes a narrated PowerPoint presentation that might be helpful in reviewing practices during meetings with your colleagues and staff.